Side branch occlusion catheter device having integrated endoscope for performing endoscopically visualized occlusion of the side branches of an anatomical passageway

ABSTRACT

The device for blocking (e.g., embolizing) the side branches of an anatomical passageway under endoscopic guidance. The device comprises an elongate catheter body having a side branch blocking apparatus, such as an embolization catheter, disposed therein and further incorporating an endoscope (e.g., an angioscope). The incorporated endoscope is useable to A) visually locate side branches which emanate from the anatomical passageway and b) visually observe the operation of the side branch blocking apparatus. Also disclosed are methods for utilizing a device of the forgoing character, including methods for performing in situ embolization of the side branches of a vein, under angioscopic visualization. The endoscopic component of the device may also be utilized to visually observe the use and/or effect of one or more separate device, such as valvulotome(s) used for cutting venous valves located within the lumen of a vein.

FIELD OF THE INVENTION

This invention relates generally to medical devices and methods, andmore particularly to an apparatus and method for performing endoluminalembolization of the side branches of a tubular anatomical passagewaysuch as a blood vessel.

BACKGROUND OF THE INVENTION

In clinical medicine, it is sometimes desirable to selectively blockcertain blood vessels or anatomical passageways of the body. Forexample, the selective blockage of blood vessels may be utilized as ameans of a) creating localized hemostasis to treat or preventhemorrhage; b) blocking blood flow through an aneurysmic region of anartery; c) blocking the blood supply to a tumor; and d) closing off theside branches of a blood vessel segment which is to be subsequentlyutilized as a graft for replacing or bypassing an occluded artery.

One particular type of surgical procedure wherein a segment of vein isutilized to bypass a blocked artery is known as an in situ vein bypassprocedure. Such in situ vein bypass procedures are often used as a meansof treating patients in whom a leg artery (e.g., the femoral artery orthe popliteal artery) has become occluded due to atheroscleroticdisease. In these procedures, a vein which runs generally parallel tothe occluded artery is prepared by a) transecting the vein at locationsabove and below the arterial blockage, b) inserting a valvulotome deviceinto the lumen of the vein segment to disrupt or lyse all venous valveslocated therewithin, and c) blocking all side branches of the veinsegment. Thereafter, the ends of the vein segment are anastomosed to theblocked artery, at locations above and below the blockage, therebyforming a bypass conduit around the arterial blockage.

In the past, the procedures used for blocking the side branches of thevein segment used in an in situ bypass procedure required either a)surgical exposure and dissection of entire vein segment to locate andligate all of the side branches which emanate therefrom, or b) the useof angiographic radiological techniques to locate the vein side branchesso that small individual incisions could be made to access and ligateeach side branch. These prior art side branch blocking procedures were,however, associated with numerous problems. For example, the opensurgical exposure and dissection of the entire vein segment resulted ina sizable incision, with accompanying potential for wound infection andpost operative discomfort. Alternatively, the use of angiographicradiological techniques for location of the side branches resulted insubstantial radiation exposure of the patient, and required theinjection of contrast media into the vein to facilitate fluoroscopicvisualization of the side branches.

More recently, efforts have been undertaken to develop simplifiedendovascular techniques whereby the side branches of the vein segmentmay be directly visualized by way of an angioscope inserted into thevein and an endovascular embolization catheter may be utilized toperform endoluminal embolization of the side branches, without requiringsurgical exposure of the side branches or the injection of radiographiccontrast fluid.

The use of these endovascular embolization catheters under directangioscopic visualization has typically required that a separateangioscope be utilized for the purpose of a) visually locating thevenous side branches and b) visually observing and guiding theendovascular side branch embolization procedure.

The manipulation and use of an angioscope which is separate from theembolization catheter has proven to be problematic. In particular, it isdifficult to maintain proper positioning of the angioscope so as to a)carefully locate all venous side branches within the vein segment and b)properly visualize and observe the endovascular side branch embolizationprocedure. Also, these procedures typically require that the separateangioscope be inserted in a direction which is retrograde to, oropposite, the direction in which the embolization catheter is inserted.This results in a less than optimal vantage point for visualizing theside branches because the normal anatomical angle of the side branchesis obtuse to the direction in which the embolization catheter isinserted, thereby resulting in the luminal openings into the sidebranches being angled away from the vantage point provided by anangioscope which has been inserted in the opposite direction.

Thus, there exists a need in the art for the development of an improvedendovascular side branch blocking device (e.g., an embolizationcatheter) which incorporates an integrated angioscope which is usable toa) clearly locate venous side branches from a vantage point located onthe device, as the device is advanced through the lumen of the veinsegment and b) visually observe and verify the blocking of each sidebranch by use of the side branch blocking device (e.g., embolizationcatheter).

SUMMARY OF THE INVENTION

The present invention provides a method and device for performingendoluminal embolization of the side branches of an anatomicalpassageway (e.g., a blood vessel) under endoscopic (e.g., angioscopic)visualization. The device of the present invention comprises a) anelongate, flexible catheter body having first and second lumensextending longitudinally therethrough; b) a side opening formed in thecatheter body near the distal end thereof, said side opening beingcommunicative with the second lumen of the catheter body; c) anembolization device disposed within the second lumen of the catheterbody and operative to pass at least one embolization member out of theside opening of the catheter body; and d) an endoscope (e.g., anangioscope) disposed within the first lumen of the catheter body, andmoveable back and forth between i) a distally advanced position whereatthe endoscope is positioned to provide viewing of an area ahead of thedistal end of the catheter body; and, ii) a proximally retractedposition whereat the endoscope is positioned to provide viewing of theside opening of the catheter body (without obstructing passage of anembolization member out of the side opening).

In accordance with the method of the present invention, the device ofthe forgoing character may be operated such that the endoscope (e.g.,angioscope) of the device is initially positioned in its distallyadvanced position to permit viewing and location of side branches whichemanate from an anatomical passageway as the catheter body is beingadvanced, distal end first, through the anatomical passageway; and,thereafter the endoscope may be subsequently retracted to its proximallyretracted position to permit viewing of the passage of an embolizationmember out of the side opening and into a side branch of the anatomicalpassageway.

Further objects and advantages of the invention will become apparent tothose skilled in the art upon reading and understanding of the followingdetailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is perspective view of one embodiment of the device of thepresent invention.

FIG. 2a is an enlarged perspective view of the distal end of the deviceof FIG. 1, with the angioscopic component of the device positioned inits distally advanced position.

FIG. 2b is an enlarged perspective view of the device of FIG. 1, withthe angioscopic component of the device in its proximally retractedposition.

FIG. 2c is an enlarged, rear, perspective view of an insert member whichforms a portion of the distal end of the device of FIG. 1.

FIG. 3a is a longitudinal sectional view of the distal end of the deviceof FIG. 1 with the angioscopic component of the device positioned in itsdistally advanced position.

FIG. 3b is a longitudinal sectional view of the distal end of the deviceof FIG. 1 with the angioscopic component of the device in its proximallyretracted position.

FIG. 4 is an enlarged elevational view of the proximal assembly portionof the device of FIG. 1.

FIG. 4a is an enlarged longitudinal sectional view of segment 4a of FIG.4.

FIG. 5a is a longitudinal sectional view through line 5--5 of FIG. 4.

FIGS. 6a-6e are a step-wise showing of a method whereby the device ofthe present invention is utilized to effect endoluminal embolization ofthe side branch of a blood vessel, under angioscopic guidance andvisualization.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description and the accompanying drawings areprovided for purposes of describing and illustrating presently preferredembodiments of the invention only, and are not intended to limit thescope of the invention in any way.

i. The Preferred Device

With reference to the accompanying figures, a preferred device 10 of thepresent invention comprises an elongate, flexible catheter body 12having a proximal end PE and a distal end DE. The catheter body 12comprises a dual lumen tube having a first lumen 14 and a second lumen16 extending longitudinally therethrough. A distal tip member 18 isattached to the distal end of the dual-lumen tube, as shown. The distaltip member 18 comprises a rigid, generally cylindrical member having adistal portion DP of a first diameter and a proximal tubular member 36of a smaller second diameter. The proximal portion PP of the distal tipmember 18 is inserted into and secured to the dual-lumen tube such thatthe distal tip member 18 forms the distal end of the catheter body 12.The distal tip member 18 includes a first luminal trough 20 which, whenproperly positioned, is in alignment with the first lumen 14 of thecatheter body 12. Also, the distal tip member 18 comprises a secondlumenal passageway 22 which, when properly positioned, is in alignmentwith the second lumen 16 of the catheter body 12 the distal face 24 ofthe distal tip member 18 is substantially closed, except for a generallyU-shaped angioscopic view port 26 formed at the distal end of the firstlumenal trough 20. In the preferred embodiment, the generally U-shapedangioscopic view port 26 has a tapered or chamfered edge, as shown.

A bulkhead 28 exists between the first lumen 14 and the second lumen 1622 of the catheter body 12. Such bulkhead 28 terminates a spaceddistance proximal to the distal face 24 of the distal tip member 18. Agenerally U-shaped angioscope supporting ledge 30 is formed immediatelyproximal to the angioscope view port 26 formed in the distal face 24 ofthe distal tip member 18. Such angioscope supporting ledge 30 is inalignment with the generally U-shaped floor of the first lumenal trough20. A side opening 32 exists within the distal tip member 18, proximalto the distal end surface 24 and distal to the distal most extent of thebulkhead 28, as shown. A curved or angular deflection surface 34 isformed in the interior of the distal tip member 18, between the distalend of the second luminal passageway 22 and the side opening 32 of thedistal tip member 18. In the embodiment shown, the deflection surface 34is of a radiused or curved configuration. It will be appreciatedhowever, that such deflection surface 34 may be in the form of anangular bend or any other shape which will deflect the advancing distaltip member 18 out of the side opening 32. A rigid sleeve member 36 isfixedly mounted within the proximal portion of the second lumenalpassageway of the distal tip member 18, and extends partially into thedistal portion DP thereof, as shown. This rigid sleeve member 36 insertsinto the second lumen 16 of the catheter body 12, beneath bulkhead 28,and serves as a guide for a distal tubular portion 40 of an embolizationdevice 42 which is disposed within the second lumen 16 of the catheterbody 12.

The embolization device 42 comprises an elongate pliable embolizationcatheter body 44 having the distal tubular member 40 extending from thedistal end thereof. A resilient embolization coil 46 is disposed withinthe lumen of the embolization catheter body 44 and or distal tubularmember 40. Such embolization coil 46 is positioned ahead of a push wire48, said push wire 48 being disposed within the lumen of the catheterbody 44.

A proximal Y-connector 50 is positioned on the proximal end of thecatheter body 12. The proximal Y-connector 50 comprises a main bodyportion 52 and a side arm 54. An extension tube 56 and embolizationdevice plunger barrel 58 extend out of the side arm 54 of the proximalY-connector 50. The catheter body 44 and push wire 48 extend through theside arm 54 of the Y-connector 50, through the tubular extension 56 andinto the interior of a plunger member 60 which is disposed within thebarrel member 58. An abutment member 62 having a generally conicaldistal surface is affixed to the outer surface of the catheter body 44.First and second telescoping tube members 45, 49 are disposed within theinterior of the plunger 60. The push wire 48 extends through the firsttelescoping tube member 45, and into the lumen of the second telescopingtube member 49, and is affixed thereto. The proximal end of the secondtelescoping tube member 49 is affixed in contact with the proximal endof the plunger 60, as shown in FIG. 5.

A rigid abutment projection 70 extends into the interior of the barrel58, and incorporates a generally conical depression 72 in the proximalend thereof. As the plunger 60 is forced in a distal direction, thegenerally conical distal surface of the abutment member 62 will abutagainst the generally conical depression of the abutment projection 70,and the generally cylindrical wall of the plunger 60 will enter thegenerally annular space 74 which surrounds the abutment projection 70.This allows the body of the plunger 60 to continue forward in the distaldirection, while the abutment member 62, which is affixed to the outersurface of the catheter body 44, is unable to travel further in thedistal direction due to its abutment against the abutment projection 70.The initial movement of the plunger 60 in the forward direction, willcause the entire catheter body 44 to move forward such that the distaltubular member 40 will slidably advance through the sleeve 36, and willimpinge against the radiused deflection surface 34 of the distal tipmember 18. Further advancement of the plunger 60 will cause the distaltubular member 40 to be directed out of the side opening 32 of thedistal tip member, by the radiused abutment surface 34, such that thedistal portion of the distal tubular member 40 protrudes outwardly fromthe catheter body 12, in a direction substantially perpendicular to thelongitudinal axis LA of the catheter body 12. Thereafter, continuedpressure against the plunger 60 will cause the cylindrical body of theplunger 60 to continue forward within the annular space 74, therebyforcing the push wire 48 to advance through the catheter body 44. Suchdistal advancement of the push wire 48 propels the embolization coil 46through the distal tubular member 40 and out of the distal end thereof.

After the embolization coil 46 has been expelled out of the distal endof the distal tubular member 40, the plunger 60 may be withdrawn in theproximal direction, thereby withdrawing the catheter body 44 and distaltubular member 40, fully into the second lumen 16 of the catheter body12. The entire plunger 60, catheter body 44 and push wire 48 may befully extracted and replaced by another replacement unit comprisinganother plunger 60, catheter body 44 and push wire 48, with yet anotherembolization coil 46 preloaded into the embolization catheter 44 asdescribed hereabove and shown in FIGS. 3a and 3b. An ovoid window 76 isformed in the body of the barrel 58 to permit the operator to observethe advancement of the catheter body 44 and conical abutment member 62as the plunger 60 is being depressed during the embolization coildeployment procedure.

Referring to the distal end DE of the scope body 82, one or moreillumination outlet ports 85 may also be provided to illuminate thevisual field of the scope 80. Alternatively, the illumination outletports 85 and image receiving port 84 may be incorporated into a singleport or lens surface whereby illuminating light is cast out of thedistal end of the scope body 82 and an optical image is concurrentlyreceived therein. The illumination outlet ports 85 are connected to oneor more bundles of illumination fibers which extend longitudinallythrough the scope body 82. Similarly, the optical image inlet port 84comprises a lens or other communication means which is connected to oneor more optical image transmitting fibers which extend longitudinallythrough the scope body 82. The scope body 82 extends through the mainbody portion 52 of the proximal connector assembly 50, and is connectedto a scope adjustment/control assembly 86. A handpiece portion 88 andproximal scope connector assembly 90 extend proximally from the scopeadjustment/control assembly 86. The proximal connector assembly 90incorporates a light source connector 92 whereby a light source may beconnected to the illumination fiber(s) of the scope so as to passilluminating light in the proximal direction through the scope body 82and out of the illumination ports 82 on the distal end thereof. Also,the proximal scope connector assembly 90 incorporates a camera connector94 whereby a camera, eye piece, video monitor, video tape recorderand/or other video viewing devices may be connected to the optical imagefibers of the scope 90 so as to electronically process and permitviewing of an optical image received through image receiving port 84.

As shown in the detailed showings of FIGS. 4 and 4a, the scopeadjustment/control assembly 86 incorporates a fine adjustment mechanism100 for precisely adjusting the longitudinal positioning of the scope 80relative to the catheter body 12 of the device so as to eliminate anyunwanted protrusion or malpositioning of the scope 80 due to variationsin the tolerances or sizing of the scope 80 relative to the catheterbody 12 of the device. Also, the scope adjustment/control assembly 86incorporates a scope advancement/retraction mechanism 102 whereby theoperator may volitionally move the scope 80 between its distallyadvanced position (FIGS. 2a, 3a) and its distally retracted position(FIGS. 2b, 3b).

The fine longitudinal adjustment mechanism 100 of the adjustment/controlassembly 86 comprises a rotatable nut 106 disposed on the proximal endof the main body portion 52 of the Y-connector assembly 50. Therotatable nut 106 has an internally threaded passageway 108 extendinglongitudinally therethrough. The scope body 82 extends through the mainbody portion 52 of the proximal Y-connector assembly 50, and through thethreaded inner passageway 108 of the rotatable nut 106. An externallythreaded member 112 engages the internal threads of the rotatable nut106. Rotation of the nut 106 in a first direction will cause theexternally threaded member 112 and scope body 82 to advance in thedistal direction, while opposite rotation of the nut 106 in the oppositedirection will cause the externally threaded member 112 and scope body82 to retract in the proximal direction. In this regard, rotatable nut106 may be utilized to effect fine adjustment of the longitudinalpositioning of the scope body 82 relative to the remainder of the device10. Such fine adjustment may be accomplished to ensure that the distalend DE of the scope body 82 is properly positioned within the view port26 prior to insertion of the device 10, thereby eliminating any improperscope positioning which could result from variability in the sizing ormanufacturing tolerance of the scope devices 80 relative to theremainder of the device 10.

Further, with specific reference to FIGS. 4 and 4a, the scopeadvancement/retraction mechanism 102 comprises a generally cylindricalouter member 120 having a plurality of annular ribs 122 formed on theouter surface thereof to prevent slippage of the operators fingers asthe annular member 120 is advanced and/or retracted. Engagement member124 is firmly affixed to the scope body 82 and to the surrounding innersurface of the cylindrical member 120. An annular spring member 130 ispositioned within an annular notch formed about the outer surface ofengagement member 124, and a series of corresponding engagement notchesor detents 131 are formed in the inner surface of the cylindrical member120. Thus, cylindrical member 120, engagement member 124, scope body 82and proximal scope connector assembly 90 may be concurrently moved backand forth, longitudinally, relative to the catheter body 12, proximalY-connector assembly 50, fine adjustment mechanism 100, and handpiece88. As such longitudinal movement is accomplished, the spring member 130will engage the individual detents 131 to bias and hold the scope body82 in selected longitudinal positions. In this regard, the operator maymanually grasp and move the cylindrical member 120 to accomplishmovement of the scope 80 between it's distally advanced position (FIGS.2a, 3a) wherein the illumination outlet ports 86 and imaging receivingport 84 of the scope 80 are positioned immediately adjacent, or within,the image receiving port 126 formed in the distal face 24 of the distaltip member 18, and the proximally retracted position (FIGS. 2b, 3b)wherein the illumination ports 86 and image receiving port 36 of thescope 80 are positioned immediately proximal to the side opening 32formed in the distal tip member 18. In this regard, when the scope 80 isin its distally advanced position (FIGS. 2a, 3a) the scope 80 may beutilized to visualize an area which is ahead of, and surrounding, thedistal end DE of the catheter body 12, thereby facilitating advancementof the catheter body 12 through a blood vessel and location of any sidebranches of the blood vessel which are to be embolized and occluded.After the side branch of a vessel has been located, the scope 80 iswithdrawn to its proximally retracted position (FIGS. 2b, 3b), wherebythe scope 80 may be utilized to ensure that the radiused deflectionsurface 34 of the distal tip member 18 is positioned immediatelyadjacent the side branch into which the embolization coil 46 is to beejected. Thereafter, the scope 80 may continue to be utilized as theplunger 60 of the embolization catheter device 42 is depressed into thebarrel 58, thereby causing the embolization catheter 44, including itsdistal tube member 40 to advance in the distal direction, beingdeflected by the radiused deflection surface 34 out of the side opening32 and into the adjacently positioned side branch of the blood vessel.Thereafter, the scope 80 may continue to be utilized to view the passageof the embolization coil 46 through the distal tubular member 40 of theembolization catheter 44 and into the adjacent side branch. Thereafter,the scope 80 may continue to be utilized to view the retraction of thedistal tube member 40 of the embolization catheter 44 into the secondlumen 16 of the catheter body 12.

Thus, the longitudinal moveability of the scope 80 between its distallyadvanced position (FIGS. 2a, 3a) and its proximally retracted position(FIGS. 2b, 3b) permits the scope 80 to be easily utilized for both theadvancement and positioning of the catheter body 12 of the device 10,and the subsequent deployment of the embolization catheter device 42into the intended side branch and ejection of the embolization coil 46thereinto.

ii. The Preferred Method

FIGS. 6a-6e provide a step-by-step illustration of a preferred method ofutilizing the device 10 to perform an endovascular side branch occlusionprocedure under angioscopic guidance.

Generally, FIG. 6a-6e show a blood vessel BV having a lumen L₁. A sidebranch SB having a side branch lumen L₂ emanates from the blood vesselBV, as shown. Also, for purposes of illustration, a venous valve VV isshown in a typical position within the lumen L₁ of blood vessel BV.

Prior to insertion of the device 10, the operator will manually ensurethat cylindrical member 120 is in its fully distally advanced positionand, thereafter, will manually rotate fine adjustment nut 106 to makecertain that the distal end of the scope body 82 is properly positionedrelative to the distal end surface 24 of the device 10. After suchvisual inspection and preparation of the device 10, the device isinserted and utilized as shown in FIGS. 6a-6e, and described herebelow.

FIG. 6a shows an initial step in the method wherein the catheter body 12of the device 10 has been inserted into the patient's vasculature andhas been advanced transluminally into the segment of blood vessel BVwherein the side branch occlusion procedure is to be performed. Thescope advancement/retraction mechanism 102 of the device 10 is manuallyadvanced to its distal-most position, thereby causing the scope 80 toassume its distally advanced position wherein the distal end of thescope body 82 is positioned within the scope view port 26 formed in thedistal face 24 of the distal tip member 18. When in such position thescope 80 provides a field of view which is ahead of the distal end DE ofthe device 10, as denoted by the shaded area in FIG. 6a. Thus, when sopositioned, the scope 80 may be utilized to discern the presence andlocation of the side branch SB, and to facilitate the proper positioningof the side opening 32 of the device 10 next to the side branch SB ofthe blood vessel BV such that an embolization coil 46 may bevolitionally passed into the side branch SB using the embolizationdevice 42 carried within the catheter body 12.

As shown in FIG. 6b, the scope advancement/retraction mechanism 102 isthen moved to its proximal-most position, thereby retracting theendoscope 80 to its proximally retracted position. When in itsproximally retracted position, the scope 80 provides a field of viewwhich includes the ostium of the side branch SB, the side opening 32 ofthe device 10, and a portion of the radius deflection surface 34 whichserves to guide the passage of the distal tubular member 40 of theembolization device 42 into the side branch SB. In this regard, theendoscope 80 is utilized to visually determine the proper positioning ofthe catheter body 12 relative to the side branch SB, such that theradiused deflection surface 34 is in alignment with the lumen L₂ of theside branch SB so as to deflect the distal tubular member 40 of theembolization device 42 into the lumen L₂ of the side branch SB.

As shown in FIG. 6c, after the distal end DE of the catheter body 12 hasbeen properly positioned, the plunger 60 is advanced into the barrel 58of the embolization device 42, thereby causing the distal tubular member40 to advance in the distal direction, and to be deflected by radiuseddeflection surface 34 into the lumen L₂ of the side branch SB.

As shown in FIG. 6d, further advancement of the plunger 60 into thebarrel 58 of the embolization device 42 causes the push wire 48 toadvance in the distal direction, thereby pushing the embolization coil46 through the lumen of the embolization catheter body 44, out of thedistal end of the distal tubular member 40 and into the lumen L₂ of theside branch SB. As the embolization coil 46 passes out of the distal endof the distal tubular member 40, the embolization coil 46 resilientlyassumes a tightly wound helical or other mass configuration, therebyforming an occlusion or blockage within the lumen L₂ of the side branchSB. After the embolization coil 46 has been fully deployed into thelumen L₂ of the side branch SB, the plunger 60 is withdrawn in theproximal direction, thereby retracting the embolization catheter body 44in the proximal direction, and causing the distal tubular member 40thereof to again become fully retracted into the second lumen 16 of thecatheter body 12 of the device 10. Thereafter, the scope 80 may again bereturned to its distally advanced position, and the catheter body 12 maybe further advanced to the site of another side branch whereat theabove-described side branch occlusion procedure is repeated.

As shown in FIG. 6e, after all of the side branches SB have beenoccluded, the device 10 is removed from the blood vessel. Theembolization coil 46 remains within the lumen L₂ of each side branch SB,as shown.

It will be appreciated that, when the scope 80 is in its distallyadvanced position, the scope 80 may be utilized to visually observe andguide the operation of a separate instrument located ahead of the distalend DE of the catheter body 12. For example, the scope 80 may bepositioned in its distally advanced position and utilized to visuallyobserve and guide the use of a separate endovascular valvulotome devicefor lysing the venous valves VV which are endogenous to the lumen L₁ ofthe blood vessel BV.

Any suitable type of valvulotome device may be utilized to cut thevenous valves VV concurrently or in conjunction with the performance ofthe side branch blocking procedure of the present invention, undervisualization by the scope 80 incorporated in the device of the presentinvention. One example of a valvulotome device which is usable inconjunction with the present invention is the device described in theUnited States Patent Application entitled METHOD AND DEVICE FORENDOLUMINAL DISRUPTION OF VENOUS VALVES (Wicherski et al) filed in evendate herewith.

To facilitate angioscopic visualization of the device 10 of the presentinvention during its use, it will be appreciated that a clear liquidsuch as 0.9% NaCl or Ringer's lactate solution may be introduced intothe lumen L of the blood vessel BV in a manner which displaces bloodfrom the lumen L and provides an optically transparent environment forvisualization by the scope 80. Such solution(s) may be infused throughan introducer sheath which surrounds the device 10, particularly incases where the device 10 has been inserted percutaneously.Alternatively, when a valvulotome device has been inserted in theretrograde or opposite direction, and is being used separately inconjunction with the device 10 of the present invention, the desiredliquid may be infused through a liquid infusion lumen of the valvulotomedevice.

Alternatively, a separate irrigation catheter may be inserted into thevein and utilized to infuse the desired liquid into the lumen L of theblood vessel BV.

As another alternative, a separate fluid infusion lumen may be formedwithin the device 10 of the present invention, and may be coupled to anoptional additional fluid infusion side arm 97 such that the desiredliquid may be infused directly through the device 10 of the presentinvention, without the need for infusion of liquid through a separateintroducer, catheter, valvulotome or other apparatus.

In summary, it is to be appreciated that the invention has beendescribed herein with reference to certain presently preferredembodiments of the invention. Various changes, alterations, additions,and deletions may be made to the above-described preferred embodimentswithout departing from the intended spirit and scope of the presentinvention. Accordingly, it is intended that all such changes,alterations, deletions and modifications be encompassed within the scopeof the following claims.

What is claimed is:
 1. A device for endoluminal embolization of the sidebranches of an anatomical passageway under endoscopic visualization,said device comprising:an elongate flexible catheter body having alongitudinal axis, a proximal end, a distal end, and at least first andsecond lumens extending longitudinally therethrough; an embolizationdevice disposed within said second lumen of said catheter body; a sideopening formed in said catheter body near the distal end thereof, saidside opening being communicative with said second lumen and defining anexit port through which said embolization device exits said catheterbody; an endoscope disposed within the first lumen of said catheterbody, said endoscope having a distal end and at least one imagereceiving port, said endoscope being alternately moveable back andforth, relative to said catheter body, between;i. a distally advancedposition whereat the image receiving port of said endoscope ispositioned distal of the exit port and to provide viewing of an areaahead of the distal end of said catheter body; and, ii. a proximallyretracted position whereat the image receiving port of said endoscope ispositioned to provide viewing of said side opening without obstructingpassage of said embolization device out of said side opening.
 2. Thedevice of claim 1 wherein:a deflection surface is formed within saidcatheter body, between the distal end of said second lumen and said sideopening formed in said catheter body; and, wherein said embolizationdevice comprises an elongate embolization catheter having a distal end,and a deflectable distal tube portion formed on the distal end thereof;said elongate embolization catheter being disposed within the secondlumen of said catheter body, and moveable back and forth therein; saiddeflection surface being configured and positioned such that, when saidembolization catheter is moved in the distal direction, the distal tubemember of said embolization catheter will contact, and be deflected by,said deflection surface, such that said distal tube member will protrudeout of the side opening of said catheter body.
 3. The device of claim 2wherein said deflection surface is of curved configuration, so as toform a curvate transitional surface between said second lumen and saidside opening of said device.
 4. The device of claim 3 wherein saidembolization member comprises a resilient embolization coil disposed, inan outstretched elongate configuration, within said embolizationcatheter, and which is resiliently biased to a coiled configuration suchthat, when expelled out of the distal end of said distal tube member,said embolization coil will assume a coiled configuration.
 5. The deviceof claim 2 wherein said deflection surface is in the form of an angularbend, thereby forming an angular transition surface between said secondlumen and said side opening of said device.
 6. The device of claim 5wherein said embolization catheter further comprises a push memberdisposed within said embolization catheter, proximal to saidembolization coil, said push wire being operative to push saidembolization coil through said catheter and out of the distal end ofsaid distal tube portion thereof, while said distal tube portionprotrudes out of the side opening of said catheter body.
 7. The deviceof claim 2 wherein said curved deflection surface is configured suchthat, when said distal tube portion of said embolization catheter isthereby deflected out of the side opening of said catheter body, saiddistal tube member will protrude from said catheter body in a directionwhich is substantially perpendicular to the longitudinal axis of saidcatheter body.
 8. The device of claim 1 wherein said endoscopecomprises:an elongate, pliable, scope body having a longitudinal axis, aproximal end and a distal end; an image receiving port formed in saidscope body; an illumination outlet port formed in said scope body; atleast one image receiving optical fiber extending longitudinally throughsaid scope body and communicative with said image receiving port; atleast one illumination transmitting fiber extending longitudinallythrough said scope body and communicative with said illumination outletport.
 9. The device of claim 8 wherein the endoscope, when in itsdistally advanced position, is located, such that the illuminationoutlet port and image receiving port of said endoscope are positioned tocast illuminating light ahead of the distal end of said catheter body;and to receive an optical image from a visual field located ahead of thedistal end of said catheter body, and when said endoscope is in saidproximally retracted position, the distal end of said endoscope islocated proximal to the side opening of said catheter body such that theillumination port of said endoscope is position to cast illuminatinglight within the side opening of said catheter body, and the imagereceiving port of said endoscope is positioned to receive a visual imagefrom a visual field which includes an area within the side opening ofsaid catheter body.
 10. The device of claim 9 wherein a shoulder isformed in the distal end of said catheter body such that the distal endof said endoscope will rest upon said shoulder when said endoscope is insaid distally advanced position.
 11. The device of claim 10 wherein saidshoulder comprises a generally U-shaped notch having a chamfered distaledge.
 12. The device of claim 1, further comprising a fine adjustmentmechanism for adjusting the longitudinal positioning of the endoscope.13. A method of blocking side branches which emanate from an anatomicalpassageway, said method comprising the steps of:a) providing a devicecomprising:an elongate flexible catheter body having a longitudinalaxis, a proximal end, a distal end, and at least first and second lumensextending longitudinally therethrough; an embolization device disposedwithin said second lumen of said catheter body; a side opening formed insaid catheter body near the distal end thereof, said side opening beingcommunicative with said second lumen and defining an exit port throughwhich said embolization device exits said catheter body; an endoscopedisposed within the first lumen of said catheter body, said endoscopehaving a distal end and at least one image receiving port, saidendoscope being alternately moveable back and forth, relative to saidcatheter body, between;i. a distally advanced position whereat the imagereceiving port of said endoscope is positioned distal of the exit portand to provide viewing of an area ahead of the distal end of saidcatheter body; and, ii. a proximally retracted position whereat theimage receiving port of said endoscope is positioned to provide viewingof said side opening without obstructing passage of said embolizationdevice out of said side opening; b) inserting said device into saidanatomical passageway; c) positioning the endoscope of said device inits distally advanced position; d) advancing said device, distal endfirst, through said anatomical passageway while observing the visualimage provided by said endoscope; e) stopping the advancement of saiddevice when the visual image of said endoscope indicates that the distalend of said endoscope is adjacent a side branch emanating from saidanatomical passageway; f) retracting said endoscope to its proximallyretracted position; g) adjusting the positioning of said device, asnecessary, to locate said side opening of said catheter body immediatelyadjacent the side branch emanating from said anatomical passageway; andh) utilizing said embolization device to pass at least one embolizationmember out of said side opening and into said side branch.
 14. Themethod of claim 13 further comprising the step of:i) returning saidendoscope to its distally advanced position; and, j) further advancingsaid device, distal end first, while monitoring the visual imageprovided by said endoscope to determine when the distal end of saiddevice has become positioned adjacent another side branch emanating fromsaid anatomical passageway.
 15. The method of claim 13 wherein saidanatomical passageway is a vein having at least one side branchemanating therefrom and at least one venous valve located therein, andwherein the endoscope of the device provided in step A of the method isfurther utilized to endoscopically view the positioning and use of avalvulotome device to cut said venous valve.
 16. A method of blockingside branches which emanate from an anatomical passageway, said methodcomprising the steps of:a) providing a device in accordance with claim6; b) inserting said device into said anatomical passageway; c)positioning said endoscope in its distally advanced position; d)advancing said device, distal end first, through said anatomicalpassageway until the distal end of said device is positioned adjacent aside branch which emanates from said anatomical passageway; e)retracting said endoscope to its proximally retracted position; f)adjusting, as necessary, the position of said device such that said sideopening is positioned next to the side branch which emanates from saidanatomical passageway; g) advancing said embolization catheter throughsaid second lumen such that the distal tube member of said embolizationcatheter is deflected by said curved deflection surface, out of the sideopening of said catheter body and into the side branch which ispositioned next to the side opening of said catheter body; h) causingsaid embolization coil to pass through said catheter body and out of thedistal end of the distal tube member thereof, such that saidembolization coil will assume its coiled configuration within said sidebranch; and, i) retracting said embolization catheter into the secondlumen of said catheter body.
 17. The method of claim 16 furthercomprising the steps of:j) returning said endoscope to its distallyadvanced position; and k) further advancing said device, distal endfirst, through said anatomical passageway until the distal end of saiddevice becomes positioned adjacent another side branch which emanatesfrom said anatomical passageway.
 18. The method of claim 16 wherein saidanatomical passageway is a vein having at least one side branchemanating therefrom and at least one venous valve located therein, andwherein the endoscope of the device provided in step A of the method isfurther utilized to endoscopically view the positioning and use of avalvulotome device to cut said venous valve.